Protocol summary
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Study aim
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Aims: Determining the effect of the oral Mullein capsules (Verbascum Sp) on the size of uterine leiomyoma and the amount of menstrual bleeding in women with asymptomatic uterine leiomyomas.
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Design
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Study design: randomized, triple-blind, placebo-controlled (the assessor, participants, and data analyzer will be unaware of the type of intervention given to every participant).Sample size: 50 persons, 25 as the intervention group and 25 in the control group. Intervention Study: The women in Intervention group will receive 400 mg oral mullein capsules twice a day for two months. Women in the control group, will receive in similar route to intervention group.
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Settings and conduct
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Iran-Tabriz, AlzahraTherapeutic Educational Center
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Participants/Inclusion and exclusion criteria
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Study population: women with asymptomatic uterine leiomyoma that Higham score before intervention is below 100. Inclusion criteria: age 18-50 years, women with at least one asymptomatic uterine fibroid larger than 2.5 cm. Exclusion criteria: pregnancy and lactation, desire to become pregnant during the next three months, uterine leiomyoma in size more than 12 cm, the size of the uterine leiomyoma equal or more than 20 weeks of gestation, anemia requiring treatment, history of chronic diseases and concurrent use of other medications or herbal remedies, history of previous surgery such as myomectomy, use of hormonal therapy in the last three months , presence of a hormonal IUD, Allergy to treatment.
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Intervention groups
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The women in Intervention group will receive 400 mg oral mullein capsules twice a day for two months
women in control group will receive 400 mg placebo capsules (containing Flour) twice a day for two months
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Main outcome variables
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Uterine leiomyomas
Menstrual bleeding loss
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017012827311N2
Registration date:
2017-02-10, 1395/11/22
Registration timing:
prospective
Last update:
2018-05-16, 1397/02/26
Update count:
1
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Registration date
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2017-02-10, 1395/11/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Tabriz University of Medical Sciences
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Expected recruitment start date
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2017-02-19, 1395/12/01
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Expected recruitment end date
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2017-07-23, 1396/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of oral Mullein capsules (Verbascum Sp) on uterine leiomyomas size and the amount of menstrual bleeding in women with asymptomatic leiomyomas : a triple blind randomised controlled trial.
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Public title
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The effect of oral Mullein capsules on the treatment of uterine leiomyomas.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: Willingness to participate in the study, having a literate and able to answer the questions, women of reproductive age 18-50 years with asymptomatic uterine leiomyomas that confirmed by abdominal ultrasound (at least one leiomyoma largest than 2.5 cm), women with normal menstruation (35-21 days).
Exclusion criteria:
Exclusion criteria: Pregnant and lactating women, desire to become pregnant during the next three months, uterine leiomyoma in size more than 12 cm, the size of the uterine leiomyoma equal or more than 20 weeks of gestation, anemia requiring treatment, history of chronic diseases (such as heart disease, thyroid, etc.) and concurrent use of other medications or herbal remedies, history of previous surgery such as myomectomy, use the OCP or other methods of hormone therapy during the last three months, presence of a hormonal IUD, known diseases of the genital tract, Allergy to treatment.
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Age
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From 18 years old to 50 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
50
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Assignment Sequence was determined using Random Computer Software (Random Allocation Software) through blocks 4 and 6 with a one to one assignment ratio. To conceal the allocation of capsules containing drugs and medicines, they were placed in the same packets of a matt burst numbered. Envelopes are numbered from 1 to 50. Sequencing and preparation of packets numbered by the person not involved in the collection and analysis of data was carried out.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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To conceal the allocation of capsules containing drugs and medicines, they were placed in the same packets of a matt burst numbered. Envelopes are numbered from 1 to 50. Sequencing and preparation of packets numbered by the person not involved in the collection and analysis of data was carried out. . In this study, the participants, the researcher and the person who examined the outcome (radiologist) were blinded to the intervention assigned to the participants.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-01-23, 1395/11/04
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Ethics committee reference number
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IR.TBZMED.REC.1395.1131
Health conditions studied
1
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Description of health condition studied
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Uterine leiomyomas
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ICD-10 code
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D25.9
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ICD-10 code description
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Leiomyoma of uterus -Leiomyoma of uterus, unspecified
Primary outcomes
1
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Description
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Size of Uterine Liomyoma
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Timepoint
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before intervention and 2 month after intervention
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Method of measurement
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Sonography study
2
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Description
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Menstrual bleeding loss
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Timepoint
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beefore intervention and 4 ,8 weeks after intervention
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Method of measurement
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Pictorial Blood Loss Assessment Chart (PBAC)
Secondary outcomes
1
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Description
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haemoglobin
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Timepoint
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before intervention and 2 months after intervention
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Method of measurement
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blood exam
2
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Description
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size of uterine
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Timepoint
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before intervention and 2 months after intervention
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Method of measurement
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Sonography study
3
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Description
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Side events
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Timepoint
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two months after intervention
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Method of measurement
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Checklist of side events
4
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Description
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Satisfaction with treatment received
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Timepoint
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two months after intervention
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Method of measurement
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Checklist of Satisfaction with treatment received
Intervention groups
1
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Description
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The women in Intervention group will receive 400 mg oral mullein capsules twice a day for two months
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Category
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Treatment - Drugs
2
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Description
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women in control group will receive 400 mg placebo capsules (containing flour) twice a day for two months
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available